Characterization of Prototype Gummy Formulations Provides Insight into Setting Quality Standards

Gummy formulations are considered suitable alternatives to traditional oral dosage forms like tablets and capsules due to their merits that include chewability, softness/flexibility, improved drug release, administration without water, appealing organoleptic properties, better patient compliance, easy preparation and usefulness for persons of different ages (e.g. children). Though there is increasing interest in gummy formulations containing drugs, measurable parameters, and specification limits for evaluating their quality are scarce. Quality check forms an essential part of the pharmaceutical development process because drug products must be distributed as consistently stable, safe, and therapeutically effective entities. Consequently, some quality parameters that could contribute to the overall performance of typical gummy formulations were investigated employing six brands of non-medicinal gummies as specimens. Accordingly, key physicochemical and micromechanical characteristics namely adhesiveness (0.009 – 0.028 mJ), adhesive force (0.009 – 0.055 N), chewiness (2.780 – 6.753 N), cohesiveness (0.910 – 0.990), hardness (2.984 – 7.453 N), springiness (0.960 – 1.000), and resilience (0.388 – 0.572), matrix firmness – compression load (2.653 – 6.753 N) and work done (3.288 – 6.829 mJ), rupture (5.315 – 29.016 N), moisture content (< 5%), weight uniformity (< 2.5 g; < 7.5% deviation), and intraoral dissolution pH (≥ 3.5 ≤ 6.8) were quantified to identify measures that may potentially function as specification limits and serve as prospective reference points for evaluating the quality of gummy formulations. Findings from this work contribute to ongoing efforts to standardize the quality control strategies for gummy formulations, particularly those intended for oral drug delivery.

Materials

Phosphate buffered saline (PBS), sodium chloride, and hydrochloric acid were purchased from Sigma-Aldrich Chemical Company (St. Louis, Missouri, USA). Vitafu-sion™ L’il Critters Immune C plus zinc (Trademarks of Church and Dwight Co., Inc, Mississauga, Ontario, Can-ada), Centrum® Junior MultiGummies (GlaxoSmithKline consumer healthcare ULC, Mississauga, Ontario, Canada), Vitafusion™ D3 for all ages (Trademarks of Church and Dwight Co., Inc, Mississauga, Ontario, Canada), Centrum® Multi Gummies Men (GlaxoSmithKline consumer health-care ULC, Mississauga, Ontario, Canada), Centrum® Multi Gummies Women (GlaxoSmithKline consumer healthcare ULC, Mississauga, Ontario, Canada), and ONE A DAY® adults’ gummies (Bayer Inc, Mississauga, Ontario, Canada) were purchased from Amazon.com Inc. (Seattle, Washing-ton, USA). All other reagents were used as received.

Adeleke, O.A., Abedin, S. Characterization of Prototype Gummy Formulations Provides Insight into Setting Quality Standards. AAPS PharmSciTech 25, 155 (2024).
https://doi.org/10.1208/s12249-024-02876-w